The FAERS website is a Federally-sponsored portal where doctors and patients can list 'adverse effects' to drugs. Prolia has been on the market in the U.S. since 2010. Yet Prolia has over 117,000 adverse effects listed, over 60,000 in one 2-year period. If you enter Prolia in the search bar in the site shown below, and give it time to load, you can read the reports, sorted in myriad ways. In December, 2020, a linked FDA report noted that Prolia is under regulatory investigation for any links to hypersensitivity vascularitis. One study showed that the newer drug by the same manifacturer, Amgen, named Evenity, did not in fact prevent the expected fractures and bone loss caused by discontinuing Prolia. The study was of only one patient but I'd bet a lot that it's the another tip of the iceberg. Speaking of tips of the iceberg, the Wall Street Journal, In an article some years ago, cited the pharmaceutical industry's estimate that fewer than 15% of real, and later-documented, adverse effects ever get reported on FAERS and that public awareness of them more frequently comes from media mention of class-action lawsuits against the manufacturer. I studied this industry in grad school and was told by senior management that the penalty for inadequate due diligence, and testing, for a new drug is cheaper than more-extensive testing and possibly finding another negative side effect. Whether that stance is more venal than good (because it can increase shareholder wealth in the interim) depends upon whose ox is being gored to misuse an old adage. I suspect that any shareholder damaged by an unwarned-against side effect would have preferred a safer drug and lower investment return though.

I promise to hereby step off this soap box in the hopes that consumers refer to FAERS and other public information, at a minimum, when deciding on medicines. Especially new drugs. Especially new drugs that cannot document long-term effective usage. Oh, and on human beings. Preferably within countries with stringent protocols and strict adherence to FDA (or tighter) guidelines.

FDA FAERS reports on adverse drug effects